Plasmasord 962000PK
Plasmasord 962000PK is a Class II device made by Gyrus Acmi, Inc., cleared under FDA 510(k) K080093 on 2 May 2008 and listed in FDA GUDID since 4 Oct 2016 (UDI-DI 00821925039490), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00821925039490 | Date4 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK080093 | Date2 May 2008 | StatusActive |
Official records
- AccessGUDID record 00821925039490
- FDA 510(k) database K080093
Across registries
- FDA 510(k) K080093 decided 2 May 2008 Active
- FDA GUDID UDI-DI 00821925039490 listed 4 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K080093
- Listed FDA GUDID 00821925039490
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Plasmasord
- Generic name
- Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
- Model / reference
- 962000PK
- Primary DI / UDI-DI
- 00821925039490
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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